Phase 4
Completed N=806
Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT01298700 ↗Enrolled (actual)
806
Serious AEs
10.7%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events — 33.3; 37.7 percentage of participants — p=0.148
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events |
33.3; 37.7 | 0.148 |
| SECONDARY Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia" |
26.0; 29.6 | — |
Eligibility Criteria
Inclusion Criteria
- Ocular hypertension or glaucoma in each eye
- Requires intraocular pressure (IOP)-lowering therapy in both eyes
- Best corrected visual acuity of 20/100 or better in each eye
Exclusion Criteria
- Ocular seasonal allergies within 2 years
- Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
- Ocular surgery or laser within 3 months
- Anticipated wearing of contact lenses during the study
Data sourced from ClinicalTrials.gov (NCT01298700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.